About leading researchers being turned down by NIH - the facts?

I just read this in a newsletter from OMF: "NIH has now denied both of our grant applications for pre-approval to apply for full grants."

For a future blog post, or open letter, I would need the facts we have about top-notch researchers being rejected when they apply for NIH grants to study ME/CFS. Would it be correct to say that we know the following things?

Top researchers with great experience and reputation find themselves rejected when they apply for NIH funds to study ME/CFS. Some examples:

- Ian Lipkin, M.D., director of Columbia University’s Center for Infection and Immunity in New York City, has been called "the world's most celebrated virus hunter". Dr Lipkin was lauded by the very NIH at the time of the XMRV studies as one of the leading researchers in his area. Yet, when Dr Lipkin has applied for grants for ME/CFS research, the NIH has turned him down, not once but twice.

- The Open Medicine Foundation's scientific board includes six members of the National Academy of Sciences and three Nobel laureates. It is chaired by Dr Ronald Davis, professor of Biochemistry and Genetics at Stanford University School of Medicine and the director of the Stanford Genome Technology Center. OMF plans cutting-edge research into ME/CFS in collaboration with Stanford University. Yet, when they have applied for NIH grants, the NIH has turned them down, twice.

Help much appreciated, both with fact-checking and phrasing (English is not my first language).

"Kitei: There’s no federal money for ME research. Year after year there’s no money, and more is given to male-patterned baldness than to this disease.

Lipkin: Let’s backtrack and examine how these decisions are made. First of all, the National Institutes of Health gets money from the Congress. The Congress will mandate what it is they want people to do. The Department of Defense has funding for autism, for a number of other things that people push, including, as you mentioned, some disorders that are specifically male.

One of them is prostate cancer. The Department of Defense has been running programs on prostate cancer for decades. Why? Because men in the position to make those decisions have wanted research focused on prostate cancer, so they allocate money for prostate cancer. The NIH doesn’t allocate money for specific disorders.Those kind of monies are allocated in response to congressional mandates.

Now, Tony Fauci doesn’t have the ability to start a brand-new program on chronic fatigue syndrome. This is what I want to do. He’s continually being pushed to work on influenza, HIV, bio-threat agents, things of that nature. And there is a portfolio for chronic fatigue syndrome, which, as you said, is quite small. There are not many people working in this field.

I have been in competition now twice to get funded, and the people there who reviewed me gave me abysmal scores. And the critiques of my work were unfair, and one of the people who critiqued my work said, in fact, that this is a psychosomatic illness. I was floored. I protested, and for reasons that are obscure to me this same individual wound up back on the study section, and I got a similar unfundable score. Am I upset about this? Absolutely. Do I think Tony Fauci knows about this? No. And if Tony Fauci were to find out that people said that he claimed this is a psychosomatic illness, he would deny it because he doesn’t believe that’s true. I’m sure he doesn’t believe that’s true....
[In the first set of critiques I was also told] that everybody knows that this is a herpes virus infection of peripheral blood mononuclear cells so there’s no reason to look at the gut. This is the nature of study sections. You can’t control what people are going to do when they get on…. They do the best that they can, but that doesn’t mean they’re up to the task and it doesn’t mean that they’re appropriate.

One of the challenges is that there aren’t enough people doing credible research in the field. Period. If there were more people, you’d have better study sections, better work and we’d be further along in terms of sorting out this problem.

Kitei: But it’s a vicious cycle. If you can’t get funding—

Lipkin: It’s not the leadership of NIH. That’s not the problem. The problem is that you need a champion in Congress who's going to go ahead and say, I want money allocated for chronic fatigue syndrome research. That’s the way it gets done. That’s the way HIV got done, that’s the way breast cancer got done, and so on. It has to be somebody who has some ability to influence the purse. And if that happens, the NIH would only be too happy to take the money and to allocate it and get the best science done. That’s all the NIH cares about.

Kitei: That’s a crazy way of doing things. If anybody should understand this disease, it’s scientists.

Lipkin: But they don’t listen to scientists. Congress doesn’t listen to scientists. They listen to people who vote for them. I was very involved in getting the autism bill passed, in the late 1990s and early 2000s. And it was two parents and a few of their friends who went down and lobbied on Capitol Hill and pushed through this first bill that created the autism Centers of Excellence. And it was the parents who did it. The problem is with chronic fatigue syndrome, and I feel bad about this, these are the most vulnerable people. They don’t have the energy or the resources that are needed to go and lobby.

Whereas if you have a child and you’re otherwise healthy, and you’re looking at this child every day, then you’re motivated, you’re strong, you’re powerful and you go down there and you complain, and push and squeak until you get the resources that you need. The other people who have the same problem are people with mental illness, and I am not saying by any means that chronic fatigue syndrome is mental illness. I’m just saying that these are also vulnerable people. Vulnerable people who do not have others looking out for them are most at risk for not getting the science that’s needed to address their problem.
But the solution for that is for the healthy ones, the people who have recovered, or relatives and friends of those who have these disorders need to push. I talk to everybody. I do everything I can to promote this. When people who are scientists tell me they don’t believe this is a real disease, I refute it, I refute it with facts, I talk to the media, but I don’t have any traction with Congress because I live in a blue state. And New York is in favor of scientific research and increasing the NIH budget. And the problem is, when you go into the South and the Midwest, you don’t have that support. The budget for the NIH has been cut dramatically.
I’m on the advisory committee for Francis Collins, and I can tell you that Francis Collins, the director of the NIH, believes that chronic fatigue syndrome is a problem. He would love to have the resources to allocate. The resources are going to have to come because people push their representatives to provide that kind of support. That's the only way it's going to happen. I’m sorry about that, because believe me, the last thing I want to do is begging for dimes and quarters for my work....Kitei: You mentioned someone on the study section said this was a psychosomatic illness. Can’t this person be educated?

Lipkin: I think this person has to be eliminated. I pushed to have him eliminated permanently from this study section. I’m not going to tell you his name because it’s not appropriate, and I’m not supposed to know it….

Kitei: That’s one person, and it would be great to get him eliminated, but there’s a basic feeling in the government—certainly in the CDC—that this is a psychosomatic illness....

Lipkin: I don’t think that’s true."

I think that the IOM and P2P reports will be a positive influence, but that to make the most of it we need to publicly apply synergistic pressure to congress, media, and the NIH. And we need to do it now.

It is difficult for PWME and their caregivers to mount noisy and sustained advocacy programs, the patients are too sick, and the caregivers are busy taking care of them.

Breast cancer research advocates' progress was fueled by their grief and unencumbered by caregiving. Susan G. Komen died of breast cancer, and her grieving daughter created a very successful breast cancer research fundraising and advocacy program.

I think the difficulty is that all scientists, even high flying ones, get their grants turned down all the time. Nobody was ever 'used to having applications approved'. Life just isn't like that in science. The chief problem I see in ME research is that we are struggling to find leads that look as if they will pay off with funding investment. Government bodies want some indication that the research has a good chance of making headway. When I sit together with ME researchers the most obvious thought in everyone's minds is that we do not have leads of the sort we would like.

Being a big shot is not a reason to have your grant approved either. The only reason to approve a grant is if it is well designed. There may be lack of interest in ME research in government funding bodies but I doubt one can improve the situation by shouting 'foul play'. What I think may be much more useful is to put pressure on ME physicians to put in good project applications based on carefully gathered preliminary data. And encourage ME charities to fund those crucial preliminary data gathering exercises.

What I think may be much more useful is to put pressure on ME physicians to put in good project applications based on carefully gathered preliminary data. And encourage ME charities to fund those crucial preliminary data gathering exercises

But, @Jonathan Edwards, if you put an application for a biomedical study in and you have a reviewer who thinks ME/CFS is psychosomatic and rejects your application because you're not proposing a psychological study, it's not an issue of study quality, surely?

And similarly if you have a reviewer who has the idea 'that everybody knows that this is a herpes virus infection of peripheral blood mononuclear cells' and rejects your application because it doesn't address that?

The chief problem I see in ME research is that we are struggling to find leads that look as if they will pay off with funding investment. Government bodies want some indication that the research has a good chance of making headway. When I sit together with ME researchers the most obvious thought in everyone's minds is that we do not have leads of the sort we would like.

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But how can anyone get leads if no-one ever funds the basic science? We're decades behind where we should be. Everyone agrees the research base is poor. We don't even have basic epidemiology.

I don't want to get too political, but you know what? It is political!

The money spent on medical research compared to other expenditures is abysmal. Add to that the fact that research for me/cfs is a low priority and we basically get a double whammy!

Barb

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Don't be disheartened. All it needs is for someone to stumble over the lead we need. My perception is that there has been a major change in the research scene with all sorts of researchers from other fields now taking an interest. If you like, Lipkin and the Norwegians were the first, but there are all sorts of other people taking interest now.

But, @Jonathan Edwards, if you put an application for a biomedical study in and you have a reviewer who thinks ME/CFS is psychosomatic and rejects your application because you're not proposing a psychological study, it's not an issue of study quality, surely?

And similarly if you have a reviewer who has the idea 'that everybody knows that this is a herpes virus infection of peripheral blood mononuclear cells' and rejects your application because it doesn't address that?

But how can anyone get leads if no-one ever funds the basic science? We're decades behind where we should be. Everyone agrees the research base is poor. We don't even have basic epidemiology.

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There are always dumb reviewers on any committee. One just has to keep trying different committees or go back when the idiots have rotated off. You get leads either by chance - as for Fluge and Mella (but chance plus a very perceptive eye for the unexpected) or by intelligent homing in on the likely options. The reality is that finding leads is the stage of research that charities dedicated to specific illnesses are most likely to fund. We also need some big infrastructural funding for the epidemiology I agree, but seeding from charities is the most likely way in even there.

Don't be disheartened. All it needs is for someone to stumble over the lead we need. My perception is that there has been a major change in the research scene with all sorts of researchers from other fields now taking an interest. If you like, Lipkin and the Norwegians were the first, but there are all sorts of other people taking interest now.

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I think things are a bit more positive and that's exciting.

But, sometimes it's hard to look at the big picture. Right now, with the political climate in the States, everything looks a bit disheartening.

There are always dumb reviewers on any committee. One just has to keep trying different committees or go back when the idiots have rotated off.

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But with ME/CFS, do the idiots ever rotate off? It used to be said of the MRC ME/CFS funding committee that biomedical proposals would get high marks from the biomedical people and low marks from the psychologists on the committee and so nothing ever got funded.

I don't understand how the NIH can have allowed someone with a psychosomatic view of ME/CFS on its screening committee so recently as 18 months ago - and if it did so then, I think it very possible that it is still doing so.

You get leads either by chance - as for Fluge and Mella (but chance plus a very perceptive eye for the unexpected) or by intelligent homing in on the likely options.

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The Lipkin work - looking at all the viruses, everything in the gut microbiome, and so on - and the genetic work that Ron Davis is doing look to me like a third approach, namely, of looking at the whole system for abnormalities and working back from there.

Maybe this is a new possibility now that 'big data' computation and high-throughput techniques are possible in a way that they weren't before?

The reality is that finding leads is the stage of research that charities dedicated to specific illnesses are most likely to fund. We also need some big infrastructural funding for the epidemiology I agree, but seeding from charities is the most likely way in even there.

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I think the situation is so dire and the unmet need so high that governments have a duty to act. I don't think our charities have anything like enough money.

I don't understand how the NIH can have allowed someone with a psychosomatic view of ME/CFS on its screening committee so recently as 18 months ago - and if it did so then, I think it very possible that it is still doing so.

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It seems to me that this element will be banished once the NIH finishes processing the IOM and P2P reports.

It used to be said of the MRC ME/CFS funding committee that biomedical proposals would get high marks from the biomedical people and low marks from the psychologists on the committee and so nothing ever got funded.

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A clear sign that the committee needs to decide whether this is a biological or mental illness and reorganize itself accordingly.

This seems to confirm what I've been thinking for a while, that any collaboration with psychobabblers is wasted time. Advancing the science conflicts with their interests. Letting them have a say in anything just lets them obstruct the process.

I suspect that ME/CFS will soon be assigned to a department which will move things forward and fund research. It is the logical response to the reports and suggestions of people like Ron Davis, Brian Vastag, and Leokitten.

I suspect that ME/CFS will soon be assigned to a department which will move things forward and fund research. It is the logical response to the reports and suggestions of people like Ron Davis, Brian Vastag, and Leokitten.

I suspect that ME/CFS will soon be assigned to a department which will move things forward and fund research. It is the logical response to the reports and suggestions of people like Ron Davis, Brian Vastag, and Leokitten.

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Maybe a pharmaceutical company will start to move things forward....as soon as they find a drug that temporarily reduces symptoms and ensures long term usage.

There are always dumb reviewers on any committee. One just has to keep trying different committees or go back when the idiots have rotated off.

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But we're not just talking about dumb reviewers. In at least one case with Lipkin, and in the case of MRC research funding as @Sasha mentioned above, we're talking about reviewers who don't even believe ME is a physiological disease. I'm sure reviewers for cancer studies or AIDS studies are frequently dumb or don't know much about the disease, and I'm sure that sometimes ends up hurting good applications in the review process. But how many leukemia grant applications get turned down because a reviewer thinks leukemia is psychosomatic? I'm guessing not many. In that respect, ME research truly is unique (or almost unique). Very few physiological diseases have to try to get grant applications through reviewers who don't believe the disease is real.

In that respect, ME research truly is unique (or almost unique). Very few physiological diseases have to try to get grant applications through reviewers who don't believe the disease is real.

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Not even the those who take a psychosomatic view of ME/CFS are saying the disease is not real. They are just saying it is maintained by psychological rather than biological factors; ie, saying it is "all in the mind".

I don't think it is unique to have grant applications thwarted because those on the applications board have a vastly different viewpoints. I communicated a while ago with a researcher from a group studying herpes simplex virus etiologies for Alzheimer's. This group get all their grant applications rejected because none of the other Alzheimer's researchers accept the idea that a subset of Alzheimer's might have a viral cause. I felt very frustrated on their behalf, because I think infectious causes of chronic disease are under-researched.